None listed
Conditions
Interventions
None listed
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women and men over 19 years of age 2. Patients with stable angina pectoris requiring percutaneous coronary intervention 3. Those who participated in this clinical trial and gave written consent to the subject description and consent form 4. Those who are willing to comply with the clinical test plan Selection criteria for cardiovascular angiography 5. If the response (low target maneuver) to be treated with arteriography is a previously untreated de novo native coronary artery lesion. 6. When the diameter of the target vessel (hereinafter referred to as the target wire) is between 2.5 mm and 4.5 mm (visual logical value). 7. When more than 50% of the target geometry is connected (visual belief)
Exclusion criteria
Exclusion criteria: 1. Those with a left ventricular ejection fraction (LVEF) of less than 30% 2. Those with a history of hypersensitivity or contraindications to stainless steel, cobalt chrome, etc., and contrast media 3. Persons with a history of hypersensitivity or contraindication to antithrombotic or anticoagulant drugs 4. Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia 5. Those with a history of bleeding diathesis or coagulopathy or who refuse blood transfusion 6. Persons with a history of stroke (CVA) or transient ischemic attack (TIA) within 4 weeks of the screening date 7. Those with a history of active peptic ulcer or upper gastrointestinal bleeding within 24 weeks of the screening date 8. Patients with confirmed acute myocardial infarction (AMI) or ST segment elevation myocardial infarction (STEMI) through electrocardiography within 72 hours of the date of procedure 9. Persons with a history of cardiogenic shock or cardiac arrest 10. Those with a history of coronary artery bypass graft (CABG) surgery 11. Persons who have undergone percutaneous coronary intervention (PCI) within 72 hours of the screening date 12. Those who experienced a major adverse cardiovascular event (MACE) or serious adverse event (SAE) after receiving percutaneous coronary intervention (PCI) within 4 weeks of the screening date. 13. Those scheduled for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 4 weeks after the end of this clinical trial 14. Those diagnosed with renal failure or those who are not suitable for angiography due to severe renal dysfunction (creatinine > 2.0 mg/dL or eGFR (estimated glomerular filtration rate) < 30 mL/min) confirmed within 1 week prior to the date of coronary angiography ruler 15. Pregnant or lactating women 16. Women of childbearing potential who plan to become pregnant during the period of participation in this clinical trial 17. Among women who may be pregnant* or men whose spouses may become pregnant, those who do not agree to contraception using a medically permitted contraceptive method** during the clinical trial period *Women of childbearing potential who have experienced menarche (women who have undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or are postmenopausal, defined as amenorrhea for more than 12 months without any other reasons, are not women of childbearing age) **Hormonal contraception, vasectomy, intrauterine device (IUD [Intrauterine device] or IUS [Intrauterine system]), tubal ligation, double barrier method (male condom, female condom, cervical cap, contraceptive diaphragm, contraceptive sponge and (combined use of the same blocking method), single blocking method using spermicide in combination 18. Those who are currently participating in another clinical trial or have participated in another clinical trial within 12 weeks of the screening date 19. In other cases, when the investigator determines that participation in the clinical trial is inappropriate because it may affect the results of the clinical trial or ethically. Exclusion criteria for coronary angiography 20. Cases where manual or mechanical thrombectomy, rotational atherectomy, or directional coronary atherectomy (DCA) are required in addition to stent placement and balloon dilatation. 21. When there are two or more blood vessels with target lesions 22. When there are two or more target lesions in one vessel 23. When the stent ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is assessed through the occurrence of treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACE) that occur in the study subjects during the clinical trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| If necessary, subgroup analysis based on the approach route for percutaneous coronary intervention (PCI) (femoral artery, radial artery) may be conducted. | — |
Countries
Korea, Republic of
Contacts
Public ContactJongyoung Lee
Kangbuk Samsung Medical Center
Outcome results
None listed